Therapeutic Effects of Physical Function and Balance of Customized Insoles on Children With Developmental Delays
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Developmental Delay
- Sponsor
- Taipei Medical University
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- change from baseline functional performance (scores) at 12 weeks
- Last Updated
- 8 years ago
Overview
Brief Summary
Using double blind, randomized controlled design to investigate the short-term therapeutic effects of function of customized insoles on children with developmental delays
Detailed Description
A total of 52 children with developmental delays will be enrolled. The participants will be randomized into two groups, including study group (with insoles) and control group (without insoles). The participants in the study group will be evaluated at baseline, that is before the customized insoles are prescribed. All of evaluations, including physical function, balance, and quality of life will be re-evaluated up to 12 weeks after insoles wearing. The control group will be evaluated at the baseline and up to 12 weeks.
Investigators
Ru-Lan Hsieh
Professor
Taipei Medical University
Eligibility Criteria
Inclusion Criteria
- •developmental delays
Exclusion Criteria
- •age less than 3 years old or older than 10 years old normal development
Outcomes
Primary Outcomes
change from baseline functional performance (scores) at 12 weeks
Time Frame: baseline and up to 12 weeks
Pediatric Outcome Data Collection Instrument
Secondary Outcomes
- change from baseline balance (scores) at 12 weeks(baseline and up to 12 weeks)
- change from baseline physical function (time) at 12 weeks(baseline and up to 12 weeks)
- change from baseline quality of life at 12 weeks(baseline and up to 12 weeks)